DD T2 Daily Disposable Registration Trial

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03305770
• Collaborator: (none)
• Enrollment: 107
• Locations: 6
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site: 17.8
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Refractive Errors	Device: verofilcon A contact lenses; Device: delefilcon A contact lenses	N/A

Detailed Description

Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: DD T2 Daily Disposable Registration Trial
• Actual Study Start Date: Oct 12, 2017
• Actual Primary Completion Date: Feb 21, 2018
• Actual Study Completion Date: Feb 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DD T2 Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.	Device: verofilcon A contact lenses; Daily disposable soft contact lenses; Other Names: DD T2
Active Comparator: DT 1 Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.	Device: delefilcon A contact lenses; Daily disposable soft contact lenses; Other Names: DAILIES TOTAL1® DT1

Outcome Measures

Primary Outcome Measures

1. Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) [Dispense, Week 1, Week 2, Month 1, Month 2, Month 3]

   VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.

• Best corrected VA 20/25 or better in each eye.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any current or prior wear experience with DT1 lenses.

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	San Diego	California	United States	92123
2	Alcon Investigative Site	Longwood	Florida	United States	32779
3	Alcon Investigative Site	Maitland	Florida	United States	32751
4	Alcon Investigative Site	Bloomington	Illinois	United States	61701
5	Alcon Investigative Site	Brentwood	Tennessee	United States	37027
6	Alcon Investigative Site	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Alcon, a Novartis Division, Alcon, a Novartis Division

Study Documents (Full-Text)

• Study Protocol - Aug 24, 2017
• Statistical Analysis Plan - Sep 22, 2017

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03305770
• Other Study ID Numbers: CLE383-C005
• First Posted: Oct 10, 2017
• Last Update Posted: Feb 22, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alcon Research: soft contact lenses; vision; eyesight
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 6 investigational sites located in the US.
Pre-assignment Detail	This reporting group includes all randomized subjects (107).

Arm/Group Title	DD T2	DT 1
Arm/Group Description	Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.	Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
Period Title: Overall Study
STARTED	70	37
Enrolled Dispensed Analysis Set	70	36
Completed Analysis Set	69	36
COMPLETED	69	36
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	DD T2	DT 1	Total
Arm/Group Description	Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.	Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.	Total of all reporting groups
Overall Participants	70	37	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.3 (6.3)	31.3 (7.6)	33.3 (6.9)
Sex: Female, Male (Count of Participants)
Female	51 72.9%	30 81.1%	81 75.7%
Male	19 27.1%	7 18.9%	26 24.3%
Race/Ethnicity, Customized (participants) [Number]
White	65 92.9%	33 89.2%	98 91.6%
Black or African American	3 4.3%	3 8.1%	6 5.6%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.4%	1 2.7%	2 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Other	1 1.4%	0 0%	1 0.9%
Multi-racial	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Description	VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Time Frame	Dispense, Week 1, Week 2, Month 1, Month 2, Month 3

Outcome Measure Data

Analysis Population Description

Completed Analysis Set

Arm/Group Title	DD T2	DT 1
Arm/Group Description	Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.	Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
Measure Participants	69	36
Measure eyes	138	72
Dispense @ 20/15	74	32
Dispense @ 20/20	62	40
Dispense @ 20/25	2	0
Dispense @ 20/30	0	0
Week 1 @ 20/15	75	36
Week 1 @ 20/20	58	36
Week 1 @ 20/25	4	0
Week 1 @ 20/30	1	0
Week 2 @ 20/15	69	35
Week 2 @ 20/20	65	37
Week 2 @ 20/25	4	0
Week 2 @ 20/30	0	0
Month 1 @ 20/15	62	31
Month 1 @ 20/20	72	40
Month 1 @ 20/25	4	1
Month 1 @ 20/30	0	0
Month 2 @ 20/15	63	33
Month 2 @ 20/20	68	36
Month 2 @ 20/25	7	3
Month 2 @ 20/30	0	0
Month 3 @ 20/15	63	35
Month 3 @ 20/20	69	37
Month 3 @ 20/25	6	0
Month 3 @ 20/30	0	0

Adverse Events

Time Frame	Dispense through study completion, an average of 15 weeks
Adverse Event Reporting Description	An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Completed Analysis Set. "At Risk" population for ocular AEs is included with unit of "eyes."
Arm/Group Title	DD T2 Ocular		DD T2 Non-ocular		DT 1 Ocular		DT 1 Non-ocular
Arm/Group Description	Eyes exposed to verofilcon A contact lenses		Subjects exposed to verofilcon A contact lenses		Eyes exposed to delefilcon A contact lenses		Subjects exposed to delefilcon A contact lenses
All Cause Mortality
	DD T2 Ocular		DD T2 Non-ocular		DT 1 Ocular		DT 1 Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/69 (0%)		0/72 (0%)		0/36 (0%)
Serious Adverse Events
	DD T2 Ocular		DD T2 Non-ocular		DT 1 Ocular		DT 1 Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/69 (0%)		0/72 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	DD T2 Ocular		DD T2 Non-ocular		DT 1 Ocular		DT 1 Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/69 (0%)		0/72 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.